Spotlight sessions at the upcoming Lyophilization USA Conference

Lyophilization is one of the most time consuming and expensive unit operations. There are many issues within lyopilization which need addressing, and improved drying technologies are needed for current and future products.

Featuring an exceptional line-up of keynote speakers from industry leading organisations, SMi’s 4th Lyophilization USA conference arrives at the perfect time to discuss novel techniques and advances; regulatory and freeze-drying challenges; finally, alternatives to conventional methods.

Agenda highlights will include a spotlight on novel PAT and QbD principles, scale up and technology transfer, bulk lyophilization, and assessing phase separation in lyophilized protein formulation.

Comparing and contrasting two methods of controlled nucleation for use in lyophilization: A live viral vaccine (LVV) perspective

  • Evaluation of two methods of controlled nucleation: pressurization / depressurization technology and “ice-fog” technology
  • Can controlled nucleation impart consistency whilst maintaining vaccine potency?
  • Impact on cycle time, consistency and moisture levels

Morrisa Jones, Senior Scientist, Vaccine Drug Product Development, Merck & Co., Inc.

 

Freeze dryer characterization and application to drug product development and scale up

  • Characterization of bench, pilot and industrial scale freeze dryers
  • Product characterization & measurement of Rp
  • Application of models to the development of a lyophilization cycle
  • Scale up
  • PAT applications to development and scale up

Timothy McCoy, Associate Director, Pharmaceutical Development, Biologics Research and Development, Sanofi

 

Challenges of lyophilized product development

  • Formulation challenges

– Excipients selection

– Dosage forms: solution, suspension, & oral melt

– Route of administration: iv, im and oral

– Solvents: aqueous and non-aqueous

– API: biologics & small molecules

  • Process challenges
  • Device selections

Yanming Zu, Director, Research and Development, Abon Pharmaceuticals

Download the brochure for a detailed program

For media enquiries, contact Jinna Sidhu on +44 (0) 20 7827 0688 or hsidhu@smi-online.co.uk

Conference: November 15 – 16, 2018

Workshops: November 14, 2018

Venue: Renaissance Woodbridge Hotel, New Jersey, USA

Website: www.lyophilization-usa.com/pr

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About SMi Group: Established since 1993, the SMi Group is a global event-production company that specializes in Business-to-Business Conferences, Workshops, Masterclasses and online Communities. We create and deliver events in the Defence, Security, Energy, Utilities, Finance and Pharmaceutical industries. We pride ourselves on having access to the world’s most forward-thinking opinion leaders and visionaries, allowing us to bring our communities together to Learn, Engage, Share and Network. More information can be found at http://www.smi-online.co.uk